FDA accepts for priority review an Apellis Pharmaceuticals supplemental NDA for Empaveli (pegcetacoplan) for treating two severe and rare kidney disea...
Despite HHS secretary Robert F. Kennedy, Jr.s promises to boost transparency at HHS and its health agencies, staff cuts now occurring will likely crip...
FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and vaccine skeptic Robert...
Corcept Therapeutics says data from its pivotal Phase 3 ROSELLA trial demonstrated that relacorilant in combination with nab-paclitaxel significantly ...
Medtronic recalls its Aortic Root Cannulas due to risks presented by unexpected loose material in the male luer used in the device.
FDA approves Bavarian Nordics freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Peter Marks departure ...
Vanda Pharmaceuticals files an NDA for Bysanti (milsaperidone) for treating acute Bipolar I disorder and schizophrenia.
FDA approves AstraZenecas Imfinzi (durvalumab) for treating adults with muscle invasive bladder cancer.